An exploratory study on the influence of Nemolizumab on Drug induced Lymphocyte Stimulation Test (DLST) in healthy volunteers and atopic dermatitis patients

JRCT ID: jRCT1050240222

Registered date:20/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 09/01/2025
• Target sample size: 15
• Study type: Observational

Outcome(s)

• Primary Outcome: DLST positive rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Healthy adults
(1) Those aged 18 to 64 years old at the time of informed consent (regardless of gender)
(2) Those who have been explained the contents of this study and have fully understood it and have given written consent to participate in this study

Atopic dermatitis patients
(1) Those aged 18 years old or older at the time of informed consent (regardless of gender)
(2) Patients who have been diagnosed with atopic dermatitis by a dermatologist and currently have symptoms
(3) Patients whose symptoms are mild to severe on the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) (Mild: 2, Moderate: 3, Severe: 4)
(4) Those who have been explained the contents of this study and have fully understood it and have given written consent to participate in this study

Exclude criteria

Healthy adults
(1) Those aged 65 or older at the time of informed consent
(2) Those who have been diagnosed with atopic dermatitis
(3) Who have ever used nemolizumab
(4) Who have had a serious accident (e.g. fainting) due to blood collection
(5) Have used prescription or over-the-counter drugs within 4 weeks of blood collection (topically acting drugs are allowed)
(6) Persons with allergy (e.g., atopic dermatitis, food allergy, asthma, allergic rhinitis, drug allergy) in the second degree of kinship (may include mild seasonal allergic rhinitis (hay fever))
(7) Persons with Chronic skin diseases (e.g., hand eczema).
(8) Has used any of the following drugs during the designation period. Topically acting drugs may be used.
(a): from 90 days prior to blood collection until the day of blood collection(Tralokinumab, Lebrikizumab)
(9) Other subjects deemed ineligible for the study by the investigator

Atopic dermatitis patients
(1)Patients who have ever used nemolizumab products
(2)Patients who have had a serious incident (e.g. syncope) due to blood sampling
(3)Patients with no symptoms (Clear: 0) or almost no symptoms (Almost clear: 1) in vIGA-AD
(4)Patients with drug allergy
(5)Persons who have used the drugs listed below during the specified period. However, topically acting drugs may be used.
(a): 1 week prior to the day of blood collection to the day of blood collection(Non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, steroids, anti-tumor agents, JAK inhibitors)
(b): 30 days prior to blood collection - day of blood collection(Dupilumab)
(c): 90 days prior to blood collection - day of blood collection(Tralokinumab, Lebrikizumab)
(6) Other subjects deemed ineligible for the study by the investigator

Related Information

• Primary Sponsor: Uratsuji Hideya
• Secondary Sponsor: Maruho Co., Ltd.